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U.S. Department of Health and Human Services

510(k) Premarket Notification
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31 to 40 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
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somnapatch Respironics, Inc. K183625 10/18/2019
matrx plus Zephyr Sleep Technologies K181996 11/21/2018
sleepimage system MyCardio, LLC dba SleepImage. K182618 08/14/2019
star 65 Skanray Technologies Pvt Ltd K172147 05/25/2018
positional sleep assessment system (posas) software Advanced Brain Monitoring K172799 03/09/2018
zmachine synergy Consolidated Research of Richmond, Inc. dba General Sleep Co K172986 12/19/2017
drowzle Resonea, Inc. K173974 07/14/2019
maxxi rip sensor Neurovirtual USA, INC. K171304 06/24/2019
tempus pro patient monitor Remote Diagnostic Technologies Ltd. K173768 01/10/2018
xacttrace single use respiratory effort belt system Embla Systems K173793 03/01/2019
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